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Multicentre observational cohort study of NSAIDs as risk factors for postoperative adverse events in gastrointestinal surgery
  1. Dmitri Nepogodiev1,
  2. Stephen J Chapman2,
  3. James C D Glasbey3,
  4. Michael Kelly4,
  5. Chetan Khatri5,
  6. J Edward Fitzgerald6,
  7. Aneel Bhangu7
  1. 1Norwich Academic Foundation Programme, Norwich, UK
  2. 2University of Leeds Medical School, Leeds, UK
  3. 3Cardiff University Medical School, Cardiff, UK
  4. 4University of Liverpool Medical School, Liverpool, UK
  5. 5Imperial College London Medical School, London, UK
  6. 6University College London, London, UK
  7. 7West Midlands Deanery General Surgery Rotation, Birmingham, UK
  1. Correspondence to Aneel Bhangu; aneelbhangu{at}doctors.org.uk

Abstract

Introduction Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended as postoperative analgesia by the Enhanced Recovery After Surgery Society. Recent studies have raised concerns that NSAID administration following colorectal anastomosis may be associated with increased risk of anastomotic leak. This multicentre study aims to determine NSAIDs’ safety profile following gastrointestinal resection.

Methods and analysis This prospective, multicentre cohort study will be performed over a 2-week period utilising a collaborative methodology. Consecutive adults undergoing open or laparoscopic, elective or emergency gastrointestinal resection will be included. The primary end point will be the 30-day morbidity, assessed using the Clavien-Dindo classification. This study will be disseminated through medical student networks, with an anticipated recruitment of at least 900 patients. The study will be powered to detect a 10% increase in complication rates with NSAID use.

Ethics and dissemination Following the Research Ethics Committee Chairperson's review, a formal waiver was received. This study will be registered as a clinical audit or service evaluation at each participating hospital. Dissemination will take place through previously described novel research collaborative networks.

  • Surgery

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

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